Each year, thousands of people may be harmed by antidiabetic medication resulting in a requirement for costly emergency medical treatment and long term care. Many of these patients have filed lawsuits against the manufacturers of the drugs that caused injury.
In the recent past, thousands of lawsuits have resulted in settlement awards in the thousands or hundreds of thousands of dollars to reimburse patients for past and future medical expenses, lost wages and pain and suffering. Some families of patients who have died after taking antidiabetic medications have been eligible for wrongful death settlements and in some cases, manufacturers have also been required to pay additional penalties for intentional wrongdoing, known as punitive damages.
Past antidiabetic drug lawsuits have claimed that companies:
- Manufactured or marketed a dangerous or defective medication
- Failed to adequately warn about risks of the medication
- Used illegal or improper marketing methods
- Hid or concealed knowledge of risks of medication
Each suspected case of medical injury is unique and though thousands of antidiabetic medication lawsuits have resulted in settlement for the plaintiff, a lawsuit is no guarantee of success and each case must be evaluated individually.
If you or a loved one have been injured by Invokamet (canagliflozin and metformin), you may be eligible for compensation.
The FDA issued a warning regarding SGLT2 inhibitor use, including Invokana and Invokamet, which stated that 20 serious adverse event reports of diabetic ketoacidosis (DKA), a potentially fatal, condition, had been received after use of SGLT2 drugs.
One of the active ingredients in Invokamet, canagliflozin as Invokana, was the subject of a consumer group objection before the medication was approved in 2013 by the Food and Drug Administration (FDA). The group, Public Citizen, objected to the medication’s approval based on a significant history of previous “new” antidiabetic medications. The group indicated that not enough safety information was available and have placed Invokana, Invokamet and other similar drugs including Farxiga on their “Do Not Use” list.
The health information data company, IMS has also identified 457 serious adverse events including diabetic ketoacidosis, related to canagliflozin and other SGLT2 inhibitors. In addition, this class of antidiabetic medications has been noted by the European Medicines Authority (EMEA) to have caused over 100 worldwide cases of diabetic ketoacidosis and at least 10 deaths in Japan may be attributed to the drugs.
Metformin, the other ingredient in Invokamet has had its share of problems as well. Problems dating back to before 2002 resulted in thousands of lawsuits regarding injuries caused by metformin containing drugs, many of which have resulted in settlements in favor of plaintiffs.
Diabetic ketoacidosis is a potential fatal serious adverse event which results from the body’s inability to utilize sugar as a cellular energy supply. This causes the body to revert to fat metabolism to supply energy, resulting in the metabolic byproduct “ketone” which results in highly acidic blood.
The FDA received at least 20 reports of Diabetic ketoacidosis prior to issuing a medical warning about the risk of the condition in patients who take the SGLT2 type medications such as Invokamet. Many type 2 diabetic patients for which the medications are prescribed will not easily identify symptoms of diabetic ketoacidosis because even though the condition is serious and potentially fatal, it is rare in Type 2 diabetics.
Beginning symptoms of DKA may include:
- Increased urination and thirst
- Abdominal pain
- Weakness and Fatigue
- “Fruity” smelling breath
- Shortness of breath
Advanced symptoms of DKA may include:
- Difficulty breathing
- Confusion, Dizziness or Fainting
Any of these symptoms should be treated as an emergency as they may become fatal.
About Type 2 Diabetes
Type 2 diabetes occurs in over 28 million Americans, largely due to obesity. The condition may also contribute to other diseases such as high blood pressure and cardiovascular disease and is caused by the body’s inability to appropriately utilize or produce enough insulin. The lack of insulin or lack of insulin effectiveness results in sugar remaining in the blood stream rather than being used by cells as energy.
When blood glucose remains too high for too long, the high sugar levels may “poison” tissues and result in blindness, kidney failure, neurologic damage and death of extremity tissues – causing the need for amputation.
About SGLT2 inhibitors and Metformin
Sugar from the blood is normally secreted and then reabsorbed by the kidneys to be used in the bloodstream. The Type 2 sodium-glucose transport or SGLT2 inhibitors such as canagliflozin, one of the ingredients in Invokamet, prevent the sugar from being absorbed so that the glucose is lost in the urine. This is a new way for antidiabetic medication to work.
Metformin, the other Invokamet ingredient, works by decreasing the amount of glucose that is released from liver storage and by decreasing absorption of sugar from the gastrointestinal tract. It is the only antidiabetic medication that works this way.
Invokana and Invokamet are both manufactured and marketed in the U.S. by Janssen, a subsidiary of the pharmaceutical giant, Johnson and Johnson which has an estimated annual revenue of over $74 billion.
Invokamet is a newer formulation but its “parent” drug, Invokana is prescribed at over 2 million prescriptions each year. The Invokana / Invokamet franchise, along with other SGLT2 inhibitors is expected to bring between $2 and $5 billion in annual revenue to the pharmaceutical industry.
Canagliflozin was not the first SGLT2 inhibitor to apply for FDA approval. The first drug was Farxiga, which was originally rejected due to concerns about its effects on the liver. Canagliflozin, one of the Invokamet ingredients was the second to apply and the first approved in 2013. Farxiga was not approved until 2014.
Metformin, the other Invokamet ingredient was approved under the brand name “Glucophage” in 2003 and has been used in combination with many other antidiabetics. Both metformin and many of the other combination drugs have been the subject of thousands of lawsuits.
Invokamet itself was approved for use in August of 2014, after multiple reports of DKA had been received by the FDA.
Invokamet Side Effects
All medications, including Invokamet may cause side effects. When considered individually, both canagliflozin and metformin carry a number of side effects, including some like DKA that may be serious or life-threatening.
Common side effects of Invokamet may include:
- Genital yeast infections (in both male and female)
- Urinary tract infection
- Sun intolerance
- Rash or itching
- Indigestion and Nausea/vomiting
- Flatulence and diarrhea
- Low Vitamin B12 levels
- Increase in LDL cholesterol
More severe side effects may include:
- Decreased kidney function
- Decreased liver function
- Allergic reactions
- Lactic acidosis, different from ketosis but also potentially fatal
The combination drug also has a number of drug interactions and should not be taken by pregnant or nursing women. Manufacturers have been ordered to undertake additional safety studies to assess for liver, cardiac and pancreatic effects and to assess the cancer and pregnancy risk.